EMA confirms metoclopramide restrictions
28th October 2013
The European Medicines Agency (EMA) has re-examined the recommended changes for metoclopramide in adults and children that it made in July 2013, following a request from one of the marketing authorization holders. It has concluded that the original advice for the use of medicines containing metoclopramide should be maintained. The following changes apply:
- metoclopramide is now only licensed for short-term use (up to 5 days). It is not licensed for use in chronic conditions such as gastroparesis, dyspepsia and gastro-oesophageal reflux disease, nor as an adjunct in surgical and radiological procedures
- in adults, metoclopramide remains licensed for prevention of post-operative nausea and vomiting (PONV), radiotherapy-induced nausea and vomiting and delayed (but not acute) chemotherapy-induced nausea and vomiting, and for symptomatic treatment of nausea and vomiting including that associated with acute migraine (where it may also be used to improve absorption of oral analgesics)
- in children, metoclopramide is only licensed as a second-line option for prevention of delayed chemotherapy-induced nausea and vomiting and treatment of established PONV. Use is contra-indicated in children under 1 year of age
- for adults and children the maximum dose is 0.5mg/kg/24h. In adults, the usual dose for all routes is 10mg up to 3 times daily. In children the recommended dose is 0.1 to 0.15mg/kg up to three times daily
- the following licensed products will be withdrawn from those countries where they are available; oral liquids containing more than 1mg/mL, intravenous formulations with concentrations above 5mg/mL and suppositories containing 20mg
- intravenous doses should be administered as a slow bolus over at least 3 minutes to reduce the risk of adverse effects
- special care should be taken in populations likely to be at increased risk of cardiovascular undesirable effects, including the elderly, patients with cardiac conduction disturbances, uncorrected electrolyte imbalance or bradycardia, and those taking other drugs known to prolong QT interval.
Patients who are currently taking regular metoclopramide should have their treatment reviewed at a routine medical appointment.
Oxybutynin elixir re-introduced to UK
25th October 2013
Oxybutynin elixir 2.5mg/5mL (Ditropan; Sanofi) has been re-introduced to the UK as a licensed product. The NHS cost of 150mL bottle = £6.88, which is approximately the same price as before it was discontinued.
Note: oxybutynin oral solution 5mg/5mL (unlicensed product) will no longer be reimbursed under part VIIIb of the specials tariff unless the prescription specifically states “unlicensed special”.
Paracetamol (acetaminophen) therapeutic review
25th October 2013
A therapeutic review on paracetamol (acetaminophen) has been published in the Journal of Pain and Symptom Management (JPSM):
Twycross R. et al (2013) Therapeutic Reviews: Acetaminophen (paracetamol). Journal of Pain and Symptom Management. 46:747 -755.
This is the 15th article in the series; all are based on monographs featured in the Palliative Care Formulary.
CQC: Safer use of controlled drugs guidance
24th October 2013
The Care Quality Commission (CQC) has developed guidance in association with NHS England for health professionals handling controlled drugs. The guidance is published on the CQC website and is intended as supporting information to be read alongside the 2012 annual report on the safer management of controlled drugs which was published in August 2013 (see our news item 13-08-2013).
There are three sections; safer use of fentanyl and buprenorphine transdermal patches, safer use of oral oxycodone medicines and safer use of MS syringe drivers. All contain information on patient safety incidents reported and a checklist for safe use.
FDA approves a new oral diclofenac formulation
24th October 2013
The US Food and Drug Administration (FDA) has approved a new oral diclofenac formulation (Zorvolex; Irko Pharmaceuticals) with altered absorption properties that allows patients to be treated with dosages 20% lower than currently available diclofenac. The capsules are 18mg or 35mg and are recommended up to three times a day. They are not interchangeable with other formulations of diclofenac. Full prescribing information can be found on the FDA website.
Update to the supply of clonazepam injection in the UK
24th October 2013
Following the discontinuation of clonazepam 1mg/mL injection (Rivotril) in the UK (see news item 10-10-2013), we can confirm that discontinuation is just in the UK. The French and Swiss Rivotril will be available via IDIS as an unauthorised (unlicensed) UK product in the next couple of weeks. However, the price for a pack of 6 (6 x 1mL ampoule of solution and 6 x 1mL ampoule of solvent) = £34.55, which is approximately 10 times the cost of the original UK product.
MHRA strengthened contra-indications for apixaban, and rivaroxaban
20th October 2013
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has strengthened contra-indications for the new oral anticoagulants apixaban (Eliquis) and rivaroxaban (Xarelto) in line with those for dabigatran (Pradaxa) that were introduced in July 2012. All three new oral anticoagulants are now contra-indicated in patients with a lesion or condition that is considered a significant risk factor for major bleeding. Examples include; current or recent gastrointestinal ulceration, malignant neoplasm at high risk of bleeding, recent brain or spinal injury or surgery, recent ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformation, vascular aneurysms, or major intraspinal or intracerebral vascular abnormalities. They are also contra-indicated in combination with any other anticoagulants except when switching therapy or when unfractionated heparin is given at doses to maintain an open central arterial/venous catheter. Full details are available in the MHRA October 2013 Drug Safety Update.
Die Juli/August Ausgabe des APM Newsletter ist fertig
16th October 2013
The July/August issue of the APM Newsletter for German-speaking users of www.palliativedrugs.com is available.
Die Juli/August Ausgabe des APM-Newsletter Jahrgang ist erschienen. Über die aktuelle Ausgaben des Newsletters wird Sie das Bulletin Board informieren.
New suppository for chronic constipation launched in UK
15th October 2013
A new type of laxative for chronic constipation has been launched in suppository form in the UK for adults and children. Lecicarbon A suppository (Aspire Pharma) contains (3-sn-Phosphatidyl)cholin = soybean oil, lecithines, as phosphatides. Small bubbles of carbon dioxide are formed when the suppository comes into contact with moisture in the rectum. Reflex bowel evacuation from the physical stimulation of the carbon dioxide produced occurs approximately 15-30min after insertion. The suppositories can also be used for bowel evacuation prior to surgical or diagnostic procedures. Use is contra-indicated in patients allergic to peanuts or soya. The NHS cost of a pack of 10 Lecicarbon A suppositories = £8.20.
TD fentanyl Cochrane review
15th October 2013
A Cochrane review on the use of transdermal fentanyl for cancer pain (CD010270.pub2), has been published.
Buprenorphine 15microgram/h TD patch launched in US
12th October 2013
A buprenorphine 15microgram/h transdermal patch (BuTrans, Purdue Pharma) is now available in the US. It is indicated for management of moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The transdermal patch is applied every 7 days and is an addition to the product range of 5, 10 and 20microgram/h transdermal patches already available.
Clonazepam injection discontinued in UK
10th October 2013
Roche has discontinued clonazepam 1mg/mL injection (Rivotril) in the UK, due to on-going supply chain difficulties and low product demand, with immediate effect. Limited emergency stock may still be available via wholesalers. There are currently no other suppliers of clonazepam injection in the UK that we are aware of. Roche medical information (0800 3281629).
World Hospice and Palliative Care Day 12 October 2013
10th October 2013
The theme for 2013 is 'Achieving universal coverage of palliative care: dispelling the myths'. For more information and to register your event visit the World Hospice and Palliative Care Day website.
PCF4+ 2013 PDF now available, special launch price of 24.99
8th October 2013
The September 2013 PDF version of the Palliative Care Formulary (PCF4+) is now available to purchase at the special launch price of £24.99 until the end of 2013 (usual price £29.99).
PCF4+ 2013 contains over 50 sections and monographs which have been updated since the publication of the PCF4 book in 2011 (ISBN 978-01-9552547-5-8) and is thus denoted PCF4+.
We anticipate publishing a PDF version annually, with the fifth edition of the book (PCF5) in 2014.
To purchase a licensed copy, and help support palliativedrugs.com, please go to the PDF section of our store.
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